Natrelle INSPIRA Breast Implants SRM-485Recalls & reported problems

Summary

The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 10888628007154), received between May 13, 2019 and Sep 24, 2026 — classified as 258 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (145 reports).

4 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 259 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Device Appears to Trigger Rejection

  Healthcare professional reported capsular contracture Baker grade IV. This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50887095 ↗
• InjurySep 7, 2026Material Rupture

  Device has been explanted and replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50649582 ↗
• InjurySep 1, 2026Material Rupture

  Healthcare professional reported: breast implant rupture. Later healthcare professional reported "hole, non-specific". This record is for the left-side device. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50551491 ↗
• InjuryAug 26, 2026Material Rupture

  Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458292 ↗
• InjuryAug 7, 2026Material Rupture

  Healthcare professional through sales representative reported "ruptured". Later healthcare professional reported "severe capsular contracture", "very painful, uncomfortable, severely misshapen" and "large protruding area on top causing disfigurement". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50178605 ↗
• InjuryAug 7, 2026Device Appears to Trigger Rejection

  Healthcare professional through sales representative reported capsular contracture Baker grade Unknown. Later healthcare professional reported "severe capsular contracture", "very painful, uncomfortable, severely misshapen". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50178373 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "grade 3 capsular contracture". This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50022295 ↗
• InjuryJul 20, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker grade III". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25882543 ↗
• InjuryJun 18, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547453 ↗
• InjuryMay 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 25144265 ↗
• InjuryMay 1, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A "RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 25059721 ↗
• InjuryApr 14, 2026Material Rupture

  PATIENT REPORTED "FEELS LIKE LUMPS AND PAIN, AND HEADACHES, AND FEELS SICK". LATER, PATIENT REPORTED "RUPTURE" VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872991 ↗
• InjuryMar 2, 2026Device Appears to Trigger Rejection; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 24483269 ↗
• InjuryJan 12, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE II, DEVICE MIGRATION/IMPLANT MALPOSITION AND ASYMMETRY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035949 ↗
• InjuryOct 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER THE HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23392614 ↗
• InjuryOct 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE III CAPSULAR CONTRACTURE". THIS RELATES TO THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23267062 ↗
• InjurySep 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23000070 ↗
• InjurySep 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¨CAPSULAR CONTRACTURE, BAKER GRADE III¨. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22979174 ↗
• InjurySep 3, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND LATER FOUND THE DEVICE TO BE RUPTURED DURING EXPLANT SURGERY. THE DEVICE WAS EXPLANTED AND DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 22958879 ↗
• InjuryAug 29, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "THOUGHT THE PATIENT HAD CAPSULAR CONTRACTURE" AND "RUPTURE" FOUND DURING EXPLANT SURGERY. LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22929233 ↗
• InjuryAug 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IF FOR LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22742359 ↗
• InjuryAug 7, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "PAIN", "CAPSULAR CONTRACTURE BAKER GRADE II" AND "POSSIBLE RUPTURE/FOLD". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22738044 ↗
• InjuryAug 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22698088 ↗
• InjuryAug 1, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE VIA CT SCAN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22685835 ↗
• InjuryJul 29, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SUSPECTED/ACTUAL RUPTURE/DEFLATION" VIA NBIR. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22651046 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

• Z-0700-2020 · Nov 6, 2019 · Terminated
  Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
• Z-0701-2020 · Nov 6, 2019 · Terminated
  Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
• Z-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
• Z-2453-2019 · Jul 24, 2019 · Open, Classified
  Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR